- September 16, 2016
- Category: Electronic batch recording software
This transition journey of Pharmaceutical industry towards electronic processes like- electronic batch recording software (EBR), supply chain management software, quality management software, distribution software and many more, would be incomplete without first mentioning the International Conference on Harmonization (ICH). ICH was formed in 1989 to bring uniformity and standardization in the formats called Common Technical Document(CTD) required for new drug applications in US, Europe and Japan because at that time the majority of new medicines were developed by these countries. ICH not only defined the fix format for CTD, but in 1994, started developing the Electronic Standards for the Transfer of Regulatory Information(ESTRI) to meet the requirements of both, Pharmaceutical companies and regulatory agencies.
This planted the seed of the FDA’s effort to encourage pharmaceutical companies to abandon their manual, paper-based processes in favor of modern technology.
Any Pharmaceutical organization is producing two things paper and drugs. To mitigate enormous paper work, in August 2002, the FDA launched a 2-year initiative, titled Pharmaceutical cGMP for the 21st Century: A risk-based approach (also known Pharmaceutical cGMP initiative). The very first objective among the various objectives put forward, was “to encourage the adoption of new technological advances by the Pharmaceutical Industry.
In these few years the market dynamics has changed a lot due to increased competition, globalization and digitization, arrival of new entrants, shortening patent cycle, merger and acquitions. This triggers the Pharmaceutical industry to bring process automation to streamline, integrate and simplify various processes like electronic batch recording (EBR), ERP, SCM, SFA, CRM and many more.
Advantages to Pharmaceutical Companies of Automated Processes
Process automation drastically reduce errors and shorten the time required to develop new products, as well as product submissions. For pharmaceutical companies, accountability is an important component of quality management and FDA compliance. Electronic batch recording software(EBR), required by FDA’s Current Good Manufacturing Practice (CGMP) regulations, demonstrate accountability by providing proof of proper handling for every step in the production of each batch of a drug product.
In fact, with a web-based delivery system, automated systems can route data from clinical trials directly to the appropriate files, allowing the submission to be developed as the data come in. This provides companies more time at the end of the clinical trial to ensure that the submission is clear, concise and correct as per the FDA guidelines. This plays a significant role in submissions timely approval.
The other benefits are:
- Enhanced transparency, security, accessibility and redundancy.
- Reduce time, cost and effort
- Improved workflows, tighter accountability, and better management of resources
- Enhanced cross-functional team communication and collaboration
- Easy to store data, copy, revise and retrieve
- Easy to conduct regular internal quality audits to ensure compliance
- External team members, such as principal investigators, contracted providers, hospitals, vendors, service providers and partners can promptly communicate problems
- Providing instant access to the most current data and information available
- With web-based system, management— even when traveling—can access and follow the development of products, as well as participate in the approval and sign off process
- Real time insights of all company activities and developments, 24-hours a day, to keep management well informed
These are the triggering points responsible for this transition of Pharmaceutical industry towards electronic processes.